Human performance or human error prevention, as it is sometimes called, is both a major challenge and a massive opportunity for the biopharmaceutical industry. Human error is a cause attributed to a considerable amount of deviations in the industry and costs the industry significant amounts of time and money. Human error causes batch failures, product recalls, and other product quality and patient safety issues; leads to accidents; and can potentially undermine regulator and investor confidence in both the boardroom and the business. Considering that, on average, a deviation can take 40 person hours simply to investigate and report, the benefits of reducing human errors are easy to see.

Unfortunately, the typical response to human errors—root cause analysis followed by corrective actions based on tired and worn-out themes, such as “Read and understand the SOP”—rarely succeeds in preventing re-occurrences, or in affecting lasting reform. How, then, can excellence in human performance be achieved?

This article is the first in a series designed to offer leaders and managers at all levels in the industry a road map to human performance excellence, the hallmark of a high reliability organization. The benefits to be had are many: high-reliability organizations enjoy reduced costs, increased efficiencies, and a competitive edge. Achieving excellence in human performance is a proven, eminently achievable system of cultivating and sustaining exceptional levels of performance. By learning from experts in the field and adapting best practices from industries renowned for human performance prowess, biopharmaceutical organizations can position themselves for excellence in human performance and the industry as a whole.

We’re Only Human
Even the use of complex automation and detailed policies, procedures, and processes can’t change the fact that biopharmaceutical organizations are run by humans, and, like it or not, humans make errors. The very nature of bioprocessing requires a substantial degree of human intervention in the execution of day-to-day operations. Not surprisingly, GMP investigations regularly uncover incidences of human errors. For some organizations, the reported incidence of human error is unacceptably high. Perhaps more damning is when the trend remains largely unchanged over the years, suggesting that, for some, it’s just become the norm and not something that is largely preventable.

This trend has heightened the concerns of the regulatory agencies, which are pushing for a more formal approach to human error prevention. Industry organizations are increasingly being tasked to “dig deeper” to discover the true causes of human errors. Notice the plural--rarely is there a single root cause and the pursuit of that alone can often blind an investigation and lead to suboptimal corrective or preventative actions.

In a presentation given at the 11th annual PDA-FDA Regulatory Conference, Rebeca Rodriguez, a National Drug Expert Investigator with FDA, noted that retraining is too often the corrective action for events deemed to be caused by human error, and that the efficacy of training as a preventive or corrective action depends on the type of human error that it is intended to prevent or correct; it is neither a panacea nor a direct route to Human Performance (1).

Rodriguez’s statement highlights the growing recognition that the biotechnology industry must implement systemic strategies and programs for human performance. Retraining for the sake of retraining will not yield high-reliability performance because it simply cannot.

Envision Excellence
For each organization, the starting point and journey to excellence in human performance will differ. There are, however, a number of fundamental challenges that must be overcome to reach world-class, game-changing levels of human performance and high-reliability performance. To begin with, know your destination. Knowing where you are going is essential for smooth travel in any journey, including the one to human performance excellence. All individuals in the organization, particularly the leaders, must understand and continually be reminded of what a high-reliability organization looks, sounds and feels like, and why they are making the journey. The benefits to be gained from making the transition to an organization where the true root causes of human errors are addressed and prevented should be clear for all to see. That clarity involves calculating the costs of human errors and expected return on investment.

Making the Journey: From Correction to Prevention
Achieving human performance excellence often involves adopting a change in perspective. Consider the following descriptions of organizational thinking procedures and culture. Those on the far right represent best practices in human performance. Where do you think your organization is currently?

Understanding Human Performance
It is important to understand that there is a difference between unintentional human errors and willful violations of practices and procedures. In the majority of cases, errors are unintentional and result from a systemic failure. The way an organization responds to human errors on all levels is one of the keys to success (see Figure 1).

Figure 1: Stupid systems not stupid people.

Taking a New Approach to Human Performance
For an organization to move towards human performance excellence, the language and actions used must reflect the belief and understanding that, in most cases, human error is the result of a systemic problem--not a human problem. Employees rarely arrive at work wanting to make an error that may jeopardize human safety and/or an organization’s viability.

At the same time, there is no gain to be had from viewing human error deviations as inevitable, not predictable or manageable, and not preventable. Human errors should be seen as weaknesses in the system, not the people, which can and should be prevented. To achieve excellence, human error reporting and investigations should be deep and lead to effective, lasting solutions. When an organization reaches human performance excellence and high-reliability, prevention is clearly working; human errors and batch failures are relentlessly reduced, the true root causes of any deviations are identified, and lessons are shared and learned well (see Figure 2).

Figure 2: Address the real root causes.

Consider the language used when a deviation occurs; where in the continuum to Human performance excellence do they fall? (See Figure 3).

Figure 3: Use language that speaks volumes.

Open Reporting
An open reporting and investigation system is another essential component of human performance excellence. All employees should feel comfortable reporting deviances and near misses, and investigations must be free of bias. The organization must move away from blame to a culture where errors are viewed as real learning opportunities and where efficient, open investigations result in effective change (see Figure 4).

Figure 4: Be open to openness.

No human is infallible. Managers must recognize that even the best, most talented and dedicated individuals can make mistakes, and it is precisely for this reason that effective error prevention strategies must be implemented and embraced. The strongest individual is the one who asks for help when needed. Human performance excellence requires being open to challenge and constructive criticism (not to be mistaken with blame). For an organization to achieve true human performance excellence, the approach to and quality of investigations is high and continually improving. Managers as well as staff are actively engaged in the process throughout, and effective solutions are put in place appropriately.
The next installment of this series will discuss key principles of success and more practical learning lessons from those leading the biopharmaceutical industry in human performance.